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JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation

ConditionsAdvanced Non-squamous Non-small-cell Lung CancerMetastatic Non-squamous Non Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAllist Pharmaceuticals, Inc.

About this trial

This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A signed written informed consent is required before performing any study-related operations

Age greater than or equal to 18 years old

Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab

No history of systemic anticancer therapy to the local advanced/metastatic disease

Disqualifiers

Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types

Carry other driver gene mutations with available target therapy, or carry other KRAS mutations

Subjects with untreated central nervous system (CNS) metastases were excluded;

Uncontrolled pleural effusion, pericardial effusion, and ascites

Trial design

Design model

Parallel

Treatments tested in this trial

  • JAB-21822

    Drug

    JAB-21822 administered orally as a tablet

  • Tislelizumab

    Drug

    Tislelizumab administered as an intravenous (IV) infusion

  • JAB-3312

    Drug

    JAB-3312 administered orally as a tablet or capsule

  • Pemetrexed

    Drug

    Pemetrexed administered as an intravenous (IV) infusion

  • Carboplatin

    Drug

    Carboplatin administered as an intravenous (IV) infusion

Treatment groups

392 Participants
are divided into 2 treatment groups
Group A: JAB-21822+JAB-3312Experimental treatment 2 interventions
Group B: Tislelizumab combined with Pemetrexed + CarboplatinActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Outcome Progression-free Survival (PFS)

PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST)v1.1, per Independent Review Committee (IRC).

Time frame
From Baseline up to 4 years

Secondary outcomes

1

Objective Response Rate (ORR)

Objective response is defined as the best overall response of complete response (CR) or partial response (PR), based on RECIST v1.1

Time frame
From Baseline up to 4 years
2

Overall Survival (OS)

OS is defined as the time from randomization until death due to any cause

Time frame
From Baseline up to 4 years
3

Number of Participants With Treatment-Emergent Adverse Events

Time frame
From Baseline up to 4 years
4

Number of Participants With Clinically Significant Changes in Vital Signs

Time frame
From Baseline up to 4 years

Other outcomes

1

Patient Self-Evaluation Results (PRO)

To be assessed by EORTC OLO-LC13

Time frame
From Baseline up to 4 years
2

Patient Self-Evaluation Results (PRO)

To be assessed by EORTC OLO-C30

Time frame
From Baseline up to 4 years
3

Patient Self-Evaluation Results (PRO)

To be assessed by EuroQoL(EQ)5D

Time frame
From Baseline up to 4 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Allist Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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